Depomed, Inc Associate Director, Technical Operations & Mftg in Lake Forest, Illinois
City Lake Forest
State Illinois [IL]
Country United States [US]
Title Associate Director, Technical Operations & Mftg
ESSENTIAL JOB FUNCTIONS
Manages and oversees tech transfer, launch, post-approval changes and routine commercial manufacturing activities at CMOs
Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.
Technical leadership in Assertio products with emphasis in process and manufacturing activities.
Helps create a manufacturing strategy for Assertio’s products, interfacing with Quality, Clinical, and Regulatory groups.
Writes/reviews batch records and protocols for manufacturing of drug products.
Writes /reviews development and validation technical reports
Oversees clinical trial material manufacturing and packaging activities and manages budgets for those projects.
Works with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
Supports manufacturing investigations and regulatory submissions.
- This position will require up to 35 % travel to contract manufacturing facilities in the US and ex-US.
EDUCATION AND EXPERIENCE
BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.
A minimum of 10 years of pharmaceutical or biotech industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments
Prior experience related to managing external CMOs is required.
Prior experience in working at a commercial manufacturing site is a plus
SKILLS AND ABILITIES
Solid problem-solving, troubleshooting and organizational skills.
Strong knowledge of pharmaceutical cGMPs.
Experience in leading cross-functional CMC teams to accomplish department goals
Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities and managing high workload projects
Familiarity with risk management strategies
Ability to work strategically and independently with internal and external groups on multiple projects
DEPOMED COMPETENCIES INCLUDE
Decisions & Judgment
Ownership & Initiative
Adaptability & Change Readiness
Teamwork & Collaboration
Assertio Therapeutic is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, orphan and specialty therapies.
Assertio has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company’s strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.
Assertio is an AA/EEO/Veterans/Disabled employer.